Kornimate/medical-research-clean huggingface dataset:
biomarkers in neurodegenerative diseases

Conditions: Mild Cognitive Impairment (MCI); Alzheimer Disease (AD); Dementia With Lewy Bodies (DLB); Frontotemporal Lobar Degeneration (FTLD); Parkinsons Disease With Dementia (PDD); Transient Epileptic Amnesia (TEA); Temporal Lobe Epilepsy (TLE); Spinocerebellar Ataxias (SCA); HIV Associated Neurocognitive Disorder (HAND); Amyotrophic Lateral Sclerosis (ALS); Primary Lateral Sclerosis (PLS)

Summary: the general purpose of this observational study is to examine biomarkers associated with the pathology of neurodegenerative diseases to potentially develop novel therapeutic approaches.


Eligibility criteria:
inclusion criteria: 1. diagnosis of mci, ad, dlb, ftld, pdd, tea, tle, sca, hand, als, pls, or normal control. 2. age 18 or older 3. reliable informant with frequent contact with participant 4. mini mental state exam (mmse) ≥15 and/or clinical dementia rating (cdr) less than 2 5. able to undergo extensive psychometric testing exclusion criteria: 1. any conditions that could account for cognitive deficits in addition to a neurodegenerative disease, including but not limited to: * past or present diagnosis of korsakoff's syndrome * alcohol or substance abuse preceding dementia \& still present within 5 years of onset * present untreated vitamin b12 or folate deficiency * present untreated hypothyroidism * past or present head trauma with persistent deficits * present untreated syphilis * past or present multiple sclerosis or another neuro-inflammatory disorder * past or present vascular or multi-infarct dementia * past or present diagnosis of huntington's disease * past or present normal pressure hydrocephalus * past or present central nervous system (cns) lesions deemed to be clinically significant * unresolved or present subdural hematoma * past or present ischemic vascular dementia * past or present intracerebral hemorrhage * present systematic liver disease * present renal insufficiency requiring dialysis * present encephalitis or meningitis * present anxiety disorder (not due to dementia and requiring medication more than 3x per week) * present severe periventricular white matter disease or greater than grade 4 white matter lesions * present lacunar infarcts deemed to clinically significant * present cortical stroke * present respiratory condition requiring oxygen 2. present significant systemic medical illness, such as cancer requiring chemotherapy or end stage cardiac insufficiency 3. present inability to safely scan in an mri 4. present pregnancy or lactation - female participants will be asked to confirm that they are not pregnant and do not plan to become pregnant. 5. present current medication likely to affect cns functions: * benzodiazepines (no triazolam, but other short-acting benzodiazepines are ok) * antidepressant therapy with amitriptyline or doxepin or tx not stable during past year * neuroleptics in the phenothiazine and haloperidol families (atypicals ok) * narcotics (codeine is ok, but hold 24 hours before neuropsychological testing) * anti-seizure medication outside of therapeutic ranges * antihistamines (\> 3x per week; hold 24 hours before neuropsychological testing)
predictive of biomarkers of healing in chronic venous ulceration of the lower limb

Conditions: Varicose Ulcer

Summary: chronic venous ulceration of the lower limb poses a significant problem to patients and healthcare providers alike. 1% of the population of western countries have either an open or healed chronic venous ulcer. however, the pathophysiological abnormalities are not entirely clear in how raised venous pressure translates into the changes seen in the skin culminating in an open ulcer. the standard treatment of this condition in the united kingdom is to undertaken compression bandaging of the lower limb. in order to further their knowledge of venous ulceration, the investigators seek to determine the biological profile of venous ulcers over a maximum of twenty-eight weeks and by dividing the groups into healing and non-healing wounds, the investigators may be able to demonstrate a difference in the biological profile. this work may provide insights into predicting who will respond to treatment and targets for treatment in the future.

forty patients with chronic venous ulceration of the lower limb who meet the inclusion criteria will be entered into the study and assessed over a twenty week period with assessments at week 0, 1, 2, 4, 8, 12 and 20. urine, serum and ulcer fluid will be sampled. if the ulcer has not healed, further assessments using an approved biological dressing will be undertaken at weeks 20, 21, 22, 23, 25 and 28 with further sampling of ulcer fluid, urine and serum. samples will undergo metabolic profiling using established metabolic profiling techniques developed at imperial college.

Eligibility criteria:
inclusion criteria: * male or female over the age of 18 years * chronic venous ulceration - defined as wound of greater than four weeks in duration between the foot and the ankle with an ankle brachial pressure index greater than 0.85. * ulceration present for at least four weeks. * colour venous duplex evidence of chronic venous insufficiency showing either reflux or obstruction. exclusion criteria: * acute infection in the studied lower limb within the last four weeks * history of malignancy in the lower limb to be studied * history of connective tissue disease * patients on medications that can cause immunosuppression - corticosteroids, chemotherapy or radiotherapy for cancer and recombinant immunological medications.

Keywords: venous ulcer leg ulcer metabolomics ulcer fluid
simultaneous integrated boost for mediastinal lymph node recurrence after radical surgery of esophageal cancer

Conditions: Esophageal Cancer; Salvage Radiotherapy; Dose-escalation; Mediastinal Lymph Node Recurrence

Summary: esophageal cancer (ec) ranks the seventh most diagnosed malignant tumor (572,000 new cases) and the sixth cancer-related mortality (509,000 deaths) worldwide in 2018. the incidence of ec is strikingly varying among the regions and sexes. approximately 70% of ec cases occur in men, and there is a 2-fold to 3-fold difference in incidence and mortality rates between regions worldwide. according to the latest reported in 2017, esophageal cancer ranks the sixth most common cancer and the fourth leading cause of cancer-mortality in china. currently, esophagectomy is considered as the standard treatment for resectable ec patients. however, the prognosis of stage iia-iii esophageal cancer after esophagectomy remains poor, and local regional lymph node recurrence is the major patterns of recurrence, and mediastinal lymph node recurrence is one of the most common sites. previous retrospective study has found that salvage chemoradiotherapy is a effective treatment option for these patients. however, the optimal dose remains unknown. in addition, no prospective trials have been conducted to investigate the efficacy and toxicities of salvage chemo-radiotherapy by using simultaneous integrated boost for the treatment of mediastinal lymph node recurrence after radical surgery of esophageal cancer


Eligibility criteria:
inclusion criteria: histo-pathologically proven diagnosis of esophageal squamous cell carcinoma. age ≥18 and ≤80 ecog performance status 0-1. clinical diagnosis of ≤5 mediastinal lymph nodes recurrence after esophagectomy. patients without distant metastasis and life expectancy ≥ 3 months. adequate liver and renal function and adequate bone marrow reservation. written, signed informed consent. exclusion criteria: prior radiotherapy to recurrence site of esophageal cancer. other co-existing malignancies or malignancies diagnosed within the last 5 years. pregnant women. women who are breastfeeding a baby. patients with uncontrolled serious medical or mental illnesses.
intravenous ketorolac for postoperative pain in laparoscopic donor nephrectomy

Conditions: Nephrectomy; Laparoscopic Donor Nephrectomy

Summary: the purpose of this study is to determine whether continuous intravenous ketorolac infusion reduces pain in patients who are having laparoscopic surgery to donate a kidney.


Eligibility criteria:
inclusion criteria: * patients donating a kidney via laparoscopic donor nephrectomy exclusion criteria: * history of nsaid allergy * asthma * history of long term opioid use * intraoperative blood loss greater than 300 ml * postoperative hemodynamic instability * active peptic ulcer disease * advanced renal impairment (cr \> 2.0 mg/dl) * bleeding diathesis * current use of probenecid * pregnancy

Keywords: laparoscopic donor nephrectomy
a long-term registry of humira® (adalimumab) in subjects with moderately to severely active crohn's disease (cd)

Conditions: Crohn's Disease

Summary: the purpose of this registry study is to evaluate the long-term safety and effectiveness of adalimumab in cd subjects who are treated as recommended in the product label.


Eligibility criteria:
inclusion criteria: * subjects who are newly prescribed humira® (adalimumab) therapy (have never been treated with adalimumab) or who are participants in abbvie sponsored investigational crohn's disease (cd) trials, are currently receiving adalimumab and for whom the treating physician has made the decision to continue with adalimumab therapy beyond the duration of the investigational trial. * subjects who were participants in abbvie sponsored investigational crohn's cd trials, who have not had dose interruptions since the last dose of study drug, where the investigator can provide source documentation of dosing information. * subjects who are currently receiving adalimumab, as per the local approved label, who have not had dose interruptions since the induction dose of adalimumab where the investigator can provide source documentation of dosing information. * subjects willing to consent to data being collected and provided to abbvie. * subjects capable of and willing to give written informed consent and to comply with the requirements of the registry study protocol. exclusion criteria: - subjects should not be enrolled if they cannot be treated in accordance with the local product label.

Keywords: crohn's disease
safety and efficacy of lebrikizumab (ly3650150) in combination with topical corticosteroid in moderate-to-severe atopic dermatitis.

Conditions: Atopic Dermatitis

Summary: this is a randomized, double-blind, placebo-controlled, parallel-group study which is 16 weeks in duration. the study is designed to evaluate the safety and efficacy of lebrikizumab when used in combination with topical corticosteroid (tcs) treatment compared with placebo in combination with tcs treatment for moderate-to-severe atopic dermatitis.


Eligibility criteria:
inclusion criteria: 1. male or female adult and adolescents (≥12 years to \<18 years, and weighing ≥40 kg). 2. chronic ad (according to american academy of dermatology consensus criteria) that has been present for ≥1 year before the screening visit. 3. eczema area and severity index (easi) score ≥16 at the baseline visit. 4. investigator global assessment (iga) score ≥3 (scale of 0 to 4) at the baseline visit 5. ≥10% body surface area (bsa) of ad involvement at the baseline visit. 6. history of inadequate response to treatment with topical medications. exclusion criteria: 1. participation in a prior lebrikizumab clinical study. 2. treatment with the following prior to the baseline visit: 1. an investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer. 2. dupilumab within 8 weeks. 3. b-cell-depleting biologics, including to rituximab, within 6 months. 4. other biologics within 5 half-lives (if known) or 16 weeks, whichever is longer. 3. treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or planned during the study. 4. uncontrolled chronic disease that might require bursts of oral corticosteroids. 5. evidence of active acute or chronic hepatitis 6. history of human immunodeficiency virus (hiv) infection or positive hiv serology at screening. 7. history of malignancy, including mycosis fungoides, within 5 years before the screening visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin. 8. pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.

Keywords: eczema dermatitis dermatitis, atopic skin diseases
prevalence-based health and economic model of the bivalent versus the quadrivalent human papillomavirus (hpv) vaccine

Conditions: Human Papillomavirus Infection

Summary: this study compares the health and economic impact of the bivalent hpv vaccine (hpv-1) and the quadrivalent hpv vaccine (hpv-2).

this study uses a prevalence-based model (by using efficacy data from each vaccine's respective trials and published cost data for taiwan) which estimates the differences in lesions, genital warts, cervical cancer and costs from a healthcare payer's perspective prevented between hpv-1 and hpv-2 vaccines during one year (when all women are vaccinated). it also analyses costs from a societal perspective.

Eligibility criteria:
inclusion criteria: * female subjects vaccinated with either hpv-1 or hpv-2 vaccines in taiwan (hypothetical group). exclusion criteria: * not applicable.

Keywords: gardasil prevalence-model cervarix economic health
can novel telemedicine tools reduce disparities related to early identification of autism

Conditions: Autism Spectrum Disorder; Developmental Delay

Summary: in this study, the investigators are trying to find new ways to screen for autism spectrum disorder (asd) in young children. the investigators want to see if people like pediatricians can screen children for asd while a psychologist watches on a monitor. the investigators are testing two screening tools. the investigators want to see if they are good at identifying children with asd and children without asd. the investigators hope this research will make it easier for families to get answers when there are concerns for asd.

the investigators will evaluate and compare two telemedicine assessment tools (tele-stat and tele-asd-peds) that could allow parents or naive providers in remote locations to complete an autism spectrum disorder (asd) risk assessment via telemedicine consultation via an expert psychologist. these tools will be low cost, compliant with privacy rules, easily deployed in community practice settings, and explicitly designed to work within paradigms that may be pragmatically and financially viable for systems of care housing remote clinicians. these telemedicine tools could provide methodologies wherein children could be rapidly linked to and appropriately assessed by asd experts within practice locations where the children are currently receiving care. in turn, these children, who without such assessment may wait months or over a year in many circumstances to access assessments and interventions, may be able to receive appropriate asd assessments within days or weeks of screening/surveillance concerns within practice settings where the children are already accessing and familiar with (i.e., minimizing loss to referral and follow-up)

Eligibility criteria:
inclusion criteria: * children who have been diagnosed with autism or developmental delay exclusion criteria: * children with genetic disorders * children with medical complexities, such as blindness or deafness * children whose families do not speak english

Keywords: telemedicine
continuous glucose monitors for children with diabetes mellitus

Conditions: Diabetes Mellitus, Insulin-Dependent

Summary: good control of blood glucose levels is important in preventing complications from diabetes. this study assessed the accuracy and reliability of two fda-approved continuous glucose monitors, the continuous glucose monitoring system (cgms) and the glucowatch g2 biographer (gw2b), in children with type 1 diabetes mellitus (t1dm).

intensive control of blood glucose levels has been shown to substantially prevent or delay complications of t1dm in adolescents and adults. the major limitation to implementation of intensive glycemic control is hypoglycemia. younger children may be at increased risk for hypoglycemia and the risk/benefit ratio of intensive glycemic control may be less favorable in this population. intensive therapy has not been systematically evaluated in children less than 13 years of age. this study was conducted by the diabetes research in children network (direcnet) to assess the accuracy of the cgms and the gw2b glucose monitors in comparison with standard blood glucose measurements in an inpatient setting. during 24-hour clinical research center stays at five clinical centers, approximately 90 children and adolescents with t1dm (1 to 17 years of age) wore two fda-approved continuous glucose monitors, cgms and gw2b, and had frequent serum glucose determinations during the day and night. to assess glucose monitor function during periods of rising and falling blood glucose, insulin-induced hypoglycemia and meal-induced hyperglycemia tests were also performed.

Eligibility criteria:
inclusion criteria * clinical diagnosis of type 1 diabetes mellitus for at least 1 year prior to study entry * for children over 2 years of age, body mass index between the 5th and 95th percentile for age and gender * weight \>= 12 kg (26.5 lbs) if \ = 16 kg (35 lbs) if \>7 years of age * normal hematocrit exclusion criteria * current use of glucocorticoids * skin or other medical disorders that would affect completion of the study * history of seizures other than those attributable to either hypoglycemia or high fever

Keywords: diabetes mellitus, insulin-dependent type 1 diabetes diabetes in children continuous glucose monitoring devices
crescnet - growth monitoring network

Conditions: Obesity; Child Development; Growth Disorders

Summary: crescnet is a network of primary care physicians and pediatricians (n=219) and endocrinological treatment centers (n=33), established in leipzig in 1998, whose aim is to improve the early detection of growth disorders. secondary to this clinical aim, epidemiological analyses, for example on secular trends of growth data of children, are performed.

pediatricians participating in crescnet provide pseudononymized data on patients' height, weight, and head circumferences to the crescnet registry. growth data are evaluated by automatized filter algorithms and by a pediatric endocrinologist. crescnet does not have access to patients or personal patient data. each participating pediatrician receives a quarterly screening report with recommendations for the work-up of children with abnormal growth or abnormal development of weight or body mass index. the data registry is used for scientific purposes.the collection of data from healthy children allows the generation of evidence based statements about prevalence rates of growth disorders and also about the rates in disorders of weight development. for this, data are provided completely anonymized without allowing conclusions on personal patient data.

Eligibility criteria:
inclusion criteria: population based sample with inclusion of any patient seen by primary care or institutional physician/pediatrician, regardless of the objective for the visit (well child visits, acute visits or special requests) exclusion criteria: none

Keywords: growth bmi obesity childhood adolescence development
xerostomia in patients with a life-limiting condition or frailty

Conditions: Xerostomia; Dry Mouth

Summary: xerostomia, the subjective feeling of dry mouth, is a common symptom during the last year of life in patients with a life-limiting condition or frailty. xerostomia leads to functional alterations (such as burning sensations, an altered taste perception, and difficulties with chewing, swallowing, and speaking), has disabling social consequences and significantly downgrades the perceived quality of life. it is an under-exposed and under-treated symptom often caused by alterations in the quality and quantity of saliva. locally administered pilocarpine could be a promising drug in this regard as it alleviates xerostomia by increasing the production of saliva.


Eligibility criteria:
inclusion criteria: * have a life-limiting condition or frailty * have the complaint dry mouth ≥ 5 on an 11 point numerical rating scale (ranging from 0= no dry mouth to 10= worst dry mouth ever) * fulfil the single sq 'would i be surprised if my patient dies within the year? (no) exclusion criteria: * their life expectancy is less than 4 weeks (the primary endpoint at 4 weeks) * they have had radiotherapy to the salivary glands or suffer from sjögrens disease (impact on dry mouth) * cognitively impaired to such an extent that there is insufficient understanding to complete questionnaires

Keywords: xerostomia dry mouth pilocarpine
bms-599626 in patients with advanced solid malignancies

Conditions: Cancer; Metastases

Summary: the purpose of this trial is to identify the highest oral dose of bms-599626, a drug that is directed against egfr and her2 proteins, that can be given safely on a daily schedule of 21 days with a 7 day rest period in patients with cancer who no longer benefit from other commonly used treatments. the study will also test for other proteins that may be affected by bms-599626; and the level of study drug in the blood will be studied.


Eligibility criteria:
inclusion criteria: * diagnosis of metastatic cancer that has progressed on currently available therapies; * at least 3 month life expectancy; * primary cancer must be solid (non-hematologic); * adequate bone marrow, liver \& kidney function; * negative pregnancy test. exclusion criteria: * serious, uncontrolled medical disorder; * individuals not willing or able to use an acceptable method to avoid pregnancy for the entire study period and for at least 3 months after the study; * pregnant or breastfeeding women; * patients with known brain metastasis; * uncontrolled or significant cardiovascular disease; * anticancer therapy within 2-6 weeks prior to study drug (depending on the therapy)

Keywords: solid tumors cancer her-2-expressing tumors
orange park out-of-hospital quality improvement study for improving cms sepsis core measures

Conditions: Sepsis; Emergency Medical Services; Quality Improvement; Shock, Septic; Fluid Therapy

Summary: the goal of this quality improvement study is to measure the impact of incorporation of a manual rapid fluid infuser (rfi) for intravenous crystalloid infusion in patients with suspected sepsis in the prehospital interval. the main question\[s\] it aims to answer are: * does the intervention affect the timeliness of fluid administration? * does the intervention affect cms sepsis bundle care measure compliance? * does the intervention affect processes and outcomes of care? * are there any adverse effects? researchers will compare this intervention to use of more conventional gravity or pressure-infusion bag crystalloid infusion.


Eligibility criteria:
inclusion criteria: patients meeting sepsis alert criteria who were transported to the study hospital's emergency department by one of the four rescue units involved in the study. sepsis alert defined as patient has suspected infection and two or more of the following: (a) temperature \> 38° c (100.4° f) or \ 20 breaths / minute or end-tidal carbon dioxide (etco2) ≤ 25 mmhg, or (c) heart rate \> 90 beats / minute exclusion criteria: * prehospital trauma * prehospital cardiac arrest prior to signaling sepsis alert * interfacility transfer * emergency transport from medical facility (e.g., medical office or clinic) * intervention by medical practitioner before emergency medical services arrival * do not resuscitate order in place